The U.S. Food and Drug Administration (FDA) has approved new automated diagnostic tests for lupus and ANCA-associated vasculitis, a form of blood vessel inflammation, Grifols, which will market these tests, announced.
The two use the HELIOS system, developed by AESKU, which is the first and only automated system capable of processing and analyzing a patient’s blood sample in a single run. This will allow labs to standardize and speed diagnosis of these autoimmune diseases using antibody detection, considered the gold-standard method.
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